WASHINGTON, D.C.—Today, National Minority Quality Forum (NMQF) announced that “Integrating Research into Community Practice — Toward Increased Diversity in Clinical Trials,” by health leaders at the U.S. Food and Drug Administration (FDA) and NMQF, has been published in the New England Journal of Medicine.
The paper details why now is the time for investments to expand access to clinical research, which is an essential component of providing equitable health care to our country’s diverse populations.
Authored by public health leaders Janet Woodcock, M.D., FDA Acting Commissioner of Food and Drugs; Richardae Araojo, Pharm.D., Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, FDA; Twyla Thompson, Pharm.D., FDA Division Director; and Gary A. Puckrein, Ph.D., NMQF President and CEO, the paper urges stakeholders in the clinical research ecosystem, from biomedical industry leaders, policymakers and government agencies, to contract research organizations and patient advocates, to support the development and long-term sustainability of an infrastructure that unites clinical research with clinical care.
“The FDA remains committed and will continue to work with all stakeholders to achieve this important goal,” said Woodcock, the lead author on the manuscript.
Physicians’ ability to extrapolate from trial results to their own patients would be dramatically improved if a trial’s participants reflected the product’s intended patient population as accurately as possible. Yet in 2020, industry-sponsored clinical trials that supported FDA approval of new molecular entities and original therapeutic biologics included 8% Black or African American, 6% Asian, and 11% Hispanic or Latino participants, according to FDA. There is considerable evidence that clinician recommendations help patients consider participating in clinical trials.
“Integrating research into community practice is critical to expanding access and advancing racial and ethnic minority participation in clinical trials,” said Araojo.
“The COVID-19 pandemic has exposed the health inequities that affect racial and ethnic minorities, as well as other underserved communities in the United States,” said Puckrein. “Increasing the diversity of participants in clinical trials is critical for America’s diverse populations. We can improve health outcomes for communities of color by increasing clinical trial access.”
To learn more, download the paper via The New England Journal of Medicine.
Kelly Ann Collins
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
About National Minority Quality Forum
The National Minority Quality Forum (NMQF) is a 501(c)(3) not-for-profit research and advocacy organization based in Washington, DC. The mission of NMQF is to reduce patient risk by assuring optimal care for all. NMQF’s vision is an American health services research, delivery and financing system whose operating principle is to reduce patient risk for amenable morbidity and mortality while improving quality of life. NMQF’s capabilities include federal and state policy analysis and advocacy; issue-specific alliance development; community-based provider quality improvement initiatives, and data analytics.